Label: FATHER JOHNS MEDICINE- dextromethorphan hbr liquid

  • NDC Code(s): 0395-9126-94, 0395-9126-98
  • Packager: Humco Holding Group, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • DOSAGE & ADMINISTRATION

    Shake well before using. Do not take more than six doses in 24 hours.

    Adults and children 12 years of age and over | 2 teaspoons every 4 hours

    Children 6 years to under 12 years of age | 1 teaspoon every 4 hours

    Children under 6 years of age | ask a doctor

  • WARNINGS

    Do not use:

    If youa re now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or parkinsons disease), or for 2 weeks after stopping the maoi drug. if you are uncertain whether your prescription contains a MAOI, consult a health professional before taking this product.

  • INACTIVE INGREDIENT

    Carmael Color

    Citric Acid

    Cod liver oil

    Flavors

    Glycerin

    Gum Arabic

    Licorice

    Purified Water

    Sodium Benzoate

    Sodium Citrate

    Sugar

  • ACTIVE INGREDIENT

    Dextrinetgirogab HBr....... 10 mg per teaspoon

  • INDICATIONS & USAGE

    Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants.

  • PURPOSE

    Cough Suppresant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

  • PRINCIPAL DISPLAY PANEL

    Father Johns Original 8oz 2022Father Johns Original 4oz 2022father

  • INGREDIENTS AND APPEARANCE
    FATHER JOHNS MEDICINE 
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    LICORICE (UNII: 61ZBX54883)  
    CLOVE OIL (UNII: 578389D6D0)  
    SUCROSE (UNII: C151H8M554)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    CARAMEL (UNII: T9D99G2B1R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    ACACIA (UNII: 5C5403N26O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9126-941 in 1 CARTON06/17/2019
    1118 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0395-9126-981 in 1 CARTON06/17/2019
    2237 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/17/2019
    Labeler - Humco Holding Group, Inc (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9126) , label(0395-9126) , analysis(0395-9126) , pack(0395-9126)
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